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Identification of Complete Lymph Node Removal by Application of Near Infrared Fluorescence Imaging in Laparoscopic and Robotic Gastrectomy

Primary Purpose

Gastric Cancer

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Near infrared fluorescence imaging during laparoscopic or robotic gastrectomy

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring near infrared, fluorescence imaging, indocyanine green, gastrectomy

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Males or Females, aged≥20 years and ≤80 years
Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 at study entry
American Society of Anesthesiolosists (ASA) score of 1 to 3
Histologically confirmed adenocarcinoma in stomach
Clinical stage I (T1N0M0, T2N0M0, T1N1M0)

5. The patient has curatively resectable disease 6. The patient has given their written informed consent to participate in the study

Exclusion Criteria:

M1 status
Experience of previous gastric resection
Complication due to gastric cancer, such as complete obstruction or perforation
History of anti-cancer therapy (chemotherapy or radiotherapy) for current gastric cancer
History of surgery, chemotherapy or radiotherapy for primary carcinoma of other organ in 5 years

Sites / Locations

Department of Surgery, Yonsei University Health System, Yonsei University College of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NIR with ICG group

Arm Description

Outcomes

Primary Outcome Measures

To compare the number of retrieved lymph node in each nodal station after additional application of near infra-red fluorescence imaging

Secondary Outcome Measures

Full Information

NCT ID

NCT01926743

First Posted

August 18, 2013

Last Updated

November 1, 2017

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT01926743

Brief Title

Identification of Complete Lymph Node Removal by Application of Near Infrared Fluorescence Imaging in Laparoscopic and Robotic Gastrectomy

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

August 1, 2013 (Actual)

Primary Completion Date

January 31, 2014 (Actual)

Study Completion Date

January 31, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Lymph node dissection in gastric cancer surgery is a very important factor not only for exact acquisition of stage but also proper treatment. Realistically, it is impossible to identify complete removal of lymph node in dissected nodal station by naked eye. The investigators can assess the route of lymphatic drainage and identify residual lymph nodes in dissected area. In the field of gastric cancer treatment, ICG and near infra-red fluorescence imaging was used only detection of sentinel lymph nodes. However, this novel concept can help to understand lymphatic drainage and make surgeons to perform D1+ or D2 lymph node dissection completely.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer

Keywords

near infrared, fluorescence imaging, indocyanine green, gastrectomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NIR with ICG group

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Near infrared fluorescence imaging during laparoscopic or robotic gastrectomy

Intervention Description

0.75mg of ICG injection around tumor each four direction by endoscopy on one or two days before surgery. NIR fluorescence imaging application during laparoscopic or robotic gastrectomy

Primary Outcome Measure Information:

Title

To compare the number of retrieved lymph node in each nodal station after additional application of near infra-red fluorescence imaging

Time Frame

About 7 days after operation when pathologic result was reported

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Males or Females, aged≥20 years and ≤80 years Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 at study entry American Society of Anesthesiolosists (ASA) score of 1 to 3 Histologically confirmed adenocarcinoma in stomach Clinical stage I (T1N0M0, T2N0M0, T1N1M0) 5. The patient has curatively resectable disease 6. The patient has given their written informed consent to participate in the study Exclusion Criteria: M1 status Experience of previous gastric resection Complication due to gastric cancer, such as complete obstruction or perforation History of anti-cancer therapy (chemotherapy or radiotherapy) for current gastric cancer History of surgery, chemotherapy or radiotherapy for primary carcinoma of other organ in 5 years

Facility Information:

Facility Name

Department of Surgery, Yonsei University Health System, Yonsei University College of Medicine

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

23645129

Citation

Marano A, Priora F, Lenti LM, Ravazzoni F, Quarati R, Spinoglio G. Application of fluorescence in robotic general surgery: review of the literature and state of the art. World J Surg. 2013 Dec;37(12):2800-11. doi: 10.1007/s00268-013-2066-x.

Results Reference

background

PubMed Identifier

21495033

Citation

Schaafsma BE, Mieog JS, Hutteman M, van der Vorst JR, Kuppen PJ, Lowik CW, Frangioni JV, van de Velde CJ, Vahrmeijer AL. The clinical use of indocyanine green as a near-infrared fluorescent contrast agent for image-guided oncologic surgery. J Surg Oncol. 2011 Sep 1;104(3):323-32. doi: 10.1002/jso.21943. Epub 2011 Apr 14.

Results Reference

background

PubMed Identifier

21996262

Citation

Rossi EC, Ivanova A, Boggess JF. Robotically assisted fluorescence-guided lymph node mapping with ICG for gynecologic malignancies: a feasibility study. Gynecol Oncol. 2012 Jan;124(1):78-82. doi: 10.1016/j.ygyno.2011.09.025. Epub 2011 Oct 11.

Results Reference

background

PubMed Identifier

19590206

Citation

Ohdaira H, Nimura H, Fujita T, Mitsumori N, Takahashi N, Kashiwagi H, Narimiya N, Yanaga K. Tailoring treatment for early gastric cancer after endoscopic resection using sentinel node navigation with infrared ray electronic endoscopy combined with indocyanine green injection. Dig Surg. 2009;26(4):276-81. doi: 10.1159/000227766. Epub 2009 Jul 8.

Results Reference

background

PubMed Identifier

15122608

Citation

Nimura H, Narimiya N, Mitsumori N, Yamazaki Y, Yanaga K, Urashima M. Infrared ray electronic endoscopy combined with indocyanine green injection for detection of sentinel nodes of patients with gastric cancer. Br J Surg. 2004 May;91(5):575-9. doi: 10.1002/bjs.4470.

Results Reference

background

PubMed Identifier

17380563

Citation

Koyama T, Tsubota A, Nariai K, Mitsunaga M, Yanaga K, Takahashi H. Novel biomedical imaging approach for detection of sentinel nodes in an experimental model of gastric cancer. Br J Surg. 2007 Aug;94(8):996-1001. doi: 10.1002/bjs.5650.

Results Reference

background

PubMed Identifier

22990053

Citation

Jeschke S, Lusuardi L, Myatt A, Hruby S, Pirich C, Janetschek G. Visualisation of the lymph node pathway in real time by laparoscopic radioisotope- and fluorescence-guided sentinel lymph node dissection in prostate cancer staging. Urology. 2012 Nov;80(5):1080-6. doi: 10.1016/j.urology.2012.05.050. Epub 2012 Sep 15.

Results Reference

background

PubMed Identifier

21853392

Citation

Cahill RA, Anderson M, Wang LM, Lindsey I, Cunningham C, Mortensen NJ. Near-infrared (NIR) laparoscopy for intraoperative lymphatic road-mapping and sentinel node identification during definitive surgical resection of early-stage colorectal neoplasia. Surg Endosc. 2012 Jan;26(1):197-204. doi: 10.1007/s00464-011-1854-3. Epub 2011 Aug 19.

Results Reference

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Identification of Complete Lymph Node Removal by Application of Near Infrared Fluorescence Imaging in Laparoscopic and Robotic Gastrectomy

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